CORE-004: CLINICAL TREATMENT UNIT AND CLINICAL TRIALS PROCESSING LABORATORY (CTU/CTPL SR) PROJECT SUMMARY / ABSTRACT The mission of the OSUCCC Clinical Treatment Unit and Clinical Trials Processing Laboratory Shared Resource (CTU/CTPL SR) is to advance the quality and efficiency of early phase clinical translational research. The CTU/CTPL SR, directed by Dr. Larry Schaaf, is composed of two different units that are intimately related: the Clinical Treatment Unit (CTU) and the Clinical Trials Processing Laboratory (CTPL). The CTU/CTPL was established in 2004 to support and expand our ability to conduct early phase trials (CTU) and the supports the processing of biospecimens for any CTO-managed trial (CTPL). It has particular expertise for, and is strategically located, supporting the OSUCCC clinical trials, especially early phase trials; 42% of the CTPL activities are for early phase trials conducted in the CTU. The CTU/CTPL was formally reviewed as a new shared resource in 2009, where funding was only requested for the CTPL. (The OSUCCC funded the CTU from institutional support, and will continue to do so). The CTPL enhances the quality of research by providing dedicated staff for high volume procurement, processing, storage, delivery, and shipment of research biospecimens critical to the correlative studies component of OSUCCC clinical trials. Highly trained staff in the CTU/CTPL SR work closely with the Clinical Trials Office (CTO) and other shared resources to provide protocol review and feasibility assessment, specimen kit assembly and distribution of specimens to internal and external research laboratories. The Specific Aims of the CTU/CTPL are: 1) to provide a stable, reliable, and cost-effective, state-of-the art unit for conducting early phase clinical trials requiring intense monitoring and/or complex correlative specimen collection; and, 2) to provide high quality, high volume specimen processing, short-term storage and distribution of biospecimens collected as correlative components of phase I, II and III translational clinical trials. During this previous grant cycle, the CTU has supported 142 protocols involving 1,354 patients with 14,490 patient visits, and the CTPL has procured and processed 82,454 research specimens on 381 protocols. During the past year, the CTU has supported 71 protocols involving 363 patients with 2,995 patient visits and the CTPL has procured and/or processed 17,875 research specimens on 216 protocols. During this time, 45 OSUCCC members, representing all five OSUCCC research programs, and accounting for 72% of the overall CTU/CTPL SR usage, have utilized the CTU/CTPL SR. The remainder of the usage was by clinical oncology faculty who work under the direct supervision of OSUCCC members. The CTPL has contributed to over 79 publications over the last five year grant period (16 with an impact factor > 10). The CTPL will continue to enhance the quality of clinical translational research conducted at the OSUCCC by providing improved efficiency, enhanced compliance, and cost-effective centralized support of early phase correlative studies. Expansion capacity is available given the additional space obtained by moving the CTU/CTPL to the new James Cancer Hospital, and the CTPL are considering expansion to additional clinical sites. The CTPL leverages extensive institutional support, and seeks only 18.9% support from CCSG funds. The Clinical Treatment Unit and Clinical Trials Processing Laboratory is part of the Clinical Grouping.